Process Engineer

  • location: Austin, TX
  • type: Permanent
  • salary: $70,000 - $85,000 per year

job description

Process Engineer

Permanent position: Leading medical device manufacturer biomedical company is seeking a process engineer for Austin, TX location. Qualified candidate must have process validation in the medical device industries. All candidates must have mechanical engineering degree or biomedical degree.

Responsibilities for the Process Engineer
  • Research, propose, purchase, and perform IQ/OQ/PQ on new equipment
  • Work with product development to plan, implement, and validate processes for new product development and product variants
  • Evaluate and document process risks and tie into validation
  • Properly document activities in accordance with best engineering practices, company procedures and cGMP, FDA, and ISO 13485 regulatory requirements
  • Knowledge of FDA regulations and guidelines for medical device process validation
  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives
Requirements for the Process Engineer

  • Bachelor's Degree in Bio Medical or Mechanical
  • Must have 3-5 years experience in small medical device manufacturing environment or some medical manufacturing with industrial background
  • Knowledge of cGMP, FDA, and ISO 13485 regulatory requirements
  • Must have process validation experience and able to manage multi projects

  • 100% paid company insurance for employee and 75% for dependent
  • 401K
  • Flex work hours
  • Stock options
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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